DxH520 Pediatric Reference Interval Verification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
研究概览
简要总结
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
详细描述
Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:
- Neonate: 0 to 30 days
- Infant: > 30 days to 2 years
- Child: 3 years to 12 years
- Adolescent: 13 years to 21 years
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Minute 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
- •Specimens should be from apparently healthy individuals.
- •Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis
排除标准
- •Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
- •Samples originating from a patient with a hematological disorder or diagnosis
- •Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge
结局指标
主要结局
Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
时间窗: 1 day
Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are: White Blood Cells (x10\^3/µL), Red Blood Cells (x10\^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10\^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10\^3/µL), Lymphocyte %, Lymphocyte Count (x10\^3/µL), Monocyte %, Monocyte Count (x10\^3/µL), Eosinophil %, Eosinophil Count (x10\^3/µL), Basophil %, Basophil Count (x10\^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.
次要结局
未报告次要终点